Kidney decline nearly halted in a phase 3 trial — plus 2 more stories

Sibeprenlimab kept kidney function almost flat for two years in IgA nephropathy

On 22 October 2026 the final two-year results of the phase 3 VISIONARY trial were published in the New England Journal of Medicine and presented at the American Society of Nephrology's Kidney Week. IgA nephropathy is an immune disease in which abnormal IgA antibodies lodge in the kidney's filters and slowly damage them, and over years many patients reach kidney failure. Sibeprenlimab (Voyxact, Otsuka) is an antibody that blocks APRIL, a signalling protein involved in producing those abnormal antibodies.

In the double-blind trial, 510 adults with biopsy-proven primary IgA nephropathy at risk of progression received sibeprenlimab or placebo on top of supportive care for two years. Kidney filtration (eGFR) changed by +0.3 mL/min/1.73 m² per year on the drug and by −4.2 on placebo, a difference of 4.5 (95% CI 3.6 to 5.4). The combined outcome of a sustained eGFR fall of at least 40%, doubling of creatinine, eGFR below 15 or start of dialysis or transplantation occurred in 1 of 259 patients on sibeprenlimab and 28 of 251 on placebo (0.4% vs 11.2%). Five people on placebo and none on the drug started kidney replacement therapy. Adverse events were similarly frequent (90.7% vs 90.0%), and serious infections were 1.9% vs 4.0%.

The trial was funded by Otsuka, and two years is short for a disease that usually progresses over decades, so the number of hard events is small. In the United States the drug has had accelerated approval since November 2025 for reducing protein in the urine of adults with this disease; its label states that slowing of kidney decline has not been established. Otsuka has now filed for full approval with these two-year data.

Retatrutide reduced breathing pauses in sleep apnoea in two phase 3 trials

On 21 October 2026 the New England Journal of Medicine published two double-blind, placebo-controlled phase 3 trials of retatrutide, an investigational medicine from Eli Lilly that acts on three hormone receptors (GIP, GLP-1 and glucagon). The participants were adults with moderate-to-severe obstructive sleep apnoea and a body-mass index of at least 27: 243 without type 2 diabetes (TRIUMPH-1-OSA) and 448 with it (TRIUMPH-2-OSA). On average they weighed about 120 and 116 kg and had 58.6 and 55.9 breathing pauses and shallow breaths per hour of sleep (the apnoea-hypopnoea index, AHI).

After 80 weeks, in people without diabetes the index fell by 34.3 and 31.7 events per hour on the two higher doses against 9.9 on placebo (differences −24.4 and −21.9). In people with diabetes it fell by 24.7 and 25.4 against 10.3 (differences −14.4 and −15.1). Body weight fell by 12.5% to 22.2% and by 12.1% to 18.5% on retatrutide, against 4.8% and 5.6% on placebo. The most common side effects were gastrointestinal.

Retatrutide is not approved for any condition. The trials were funded by Eli Lilly, included only adults with excess weight, and measured breathing during sleep and weight rather than heart attacks, strokes or survival. The trials did not test whether these changes reduce cardiovascular events or improve survival.

AI for lung blood clots caught fewer small clots in everyday use than in its clearance data

On 21 October 2026 npj Digital Medicine published a retrospective check of two FDA-cleared algorithms from Aidoc's BriefCase platform across a 17-facility academic health system in the United States, led by radiologists at Emory University. One algorithm flags pulmonary embolism, a clot blocking an artery in the lungs, on dedicated CT pulmonary angiograms (30,678 scans); the other flags clots found incidentally on routine contrast CT scans (37,191 scans).

The pulmonary embolism model found 86.8% of clots, with specificity of 99.1%. It found 99.3% of the largest, saddle clots but 72.9% of the smallest, subsegmental ones, and 89.7% of acute against 65.3% of older, non-acute clots. The incidental-clot model found 73.5% of clots, with specificity of 99.8%. Both models had lower sensitivity than in the benchmarks used for FDA clearance and higher specificity.

The reference standard was the radiologists' reports, read by a validated language-model pipeline (97% accuracy), rather than a fresh review of every image. The study did not measure whether patients were treated faster or did better. Aidoc supplied the algorithm outputs and had no role in the analysis, and the authors received no specific funding. The drop in sensitivity for small and older clots mirrors known limits of human readers, and the authors call for standard post-market monitoring of AI medical devices.

This material is for information only and does not replace a consultation with a doctor. Nothing in it is a recommendation to start, stop or change treatment.

Sources

• Rizk DV, Barratt J, Suzuki Y, et al. Sibeprenlimab in IgA Nephropathy: Final Phase 3 Trial Analysis. N Engl J Med. 2026. doi:10.1056/NEJMoa2609127

• Otsuka. Final Phase 3 VISIONARY results at ASN. 22 October 2026. otsuka-us.com

• Trial of Sibeprenlimab in the Treatment of IgA Nephropathy (VISIONARY). ClinicalTrials.gov. NCT05248646

• Grunstein RR, et al. Retatrutide Once Weekly for Treatment of Obstructive Sleep Apnea. N Engl J Med. 2026. PMID 42904878

• TRIUMPH-1 and TRIUMPH-2. ClinicalTrials.gov. NCT05929066, NCT05929079

• Mansuri A, Chavoshi M, et al. Multi-site real-world performance of commercial AI for pulmonary and incidental pulmonary embolism detection. npj Digit Med. 2026. doi:10.1038/s41746-026-03418-3